A randomized, placebo-controlled, double blind human trial into the effect of Protecflor on gastroenteritis caused by attenuated E. Coli

Completed

Conditions: gastroenteritis
traveler's diarrhea
10017966
10004018

Registration Number: NL-OMON37365

Lead Sponsor: allemand Human Nutrition

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- Healthy male subjects, aged 20-55 yrs, living in the Ede/Wageningen neighbourhood
- Informed consent
- Availability of internet connection
- Willingness to replace habitual dairy product intake with the supplied low-calcium soy products
- Willingness to abstain from products with high amounts of prebiotic fibers and from products with probiotics (except for the supplied one) starting 1 month prior to study start
- Willingness to give up blood donation from 1 month before the start of the experiment and during the entire experimental period.

Exclusion Criteria

- Current or previous underlying disease of the GI tract
- Allergy to milk products or lactose intolerance (self-reported), since the capsules may contain milk traces from culture media
- Allergy to soy products (self-reported)
- Use of antibiotics, norit, laxatives (up till 6 months prior to inclusion), cholestyramine, acid burn inhibitors or immune suppressive (up till 3 months prior to inclusion), and pre- and probiotics (up till 1 month prior to inclusion).
- High titer serum antibodies against ETEC (10 ml blood sample collected at screening).
- Vegetarians
- Vegans
- Heavy alcohol use (>4 consumptions/day or >20/week)
- Drug use

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Faecal ETEC excretion with time as marker of the colonization resistance<br /><br>- Total daily faecal output as marker of diarrhea</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Bowel habits<br /><br>- Frequency and severity of gastrointestinal symptoms<br /><br>- Diarrhea severity (as measured by faecal dry weight excretion and % faecal<br /><br>dry weight)<br /><br>- Specific serum antibody response to CFA-II<br /><br><br /><br>Tertiary study outcomes (performance will depend on results primary and<br /><br>secundary markers)<br /><br>- Opportunistic pathogens in faeces<br /><br>- Calprotectin<br /><br>- Total faecal sIgA</p><br>